Promising Partner Leads
An emerging player on the industry side is Otsuka Pharmaceuticals, which is the largest single funder of clinical development
work on medicines to treat MDR TB. It ranks third—after the Gates Foundation and the US National Institutes of Health—in spending
against TB overall. "Otsuka is unique in several ways: we are ahead in advanced testing of promising compounds to attack
MDR, our commercial commitment to TB is the focus of a special business unit, and we pay all the costs associated with clinical
trials ourselves," Patrizia Carlevaro, a Lilly veteran who now heads, among other activities, Otsuka's global TB health awareness
programs, tells Pharm Exec.
Most important, Otsuka, along with J&J's Tibotec division, is top of the list on prospects for approval of the first new treatment
for TB in more than 40 years. Delamanid, a highly potent compound in the nitroimidazole class, began clinical trials in 2004
and recently has shown encouraging results in countering MDR in a large-scale Phase II (b) trial. Otsuka intends to carry
these results forward to Phase III and possible approval by licensing authorities in the near future. The Tibotec entry, TMC-207,
is also showing gains against MDR in a trial that Tibotec is leading.
Says Carlevaro, "The premise behind a strong PDP is that each party performs to its strengths. Industry must focus on science
and clinical development, while ensuring synergies with NGOs, governments, and international organizations in developing programs
linked to access and care." She adds that the goal of a PDP is analogous to a disease management scheme. "What remains to
be done is the cost-efficient execution of a package of customized services that take the patient from diagnosis, to treatment,
Evidence that this approach is already working is the recent rollout of a new, simplified diagnostic for TB, GeneXpert, that
permits a clinician to identify positives for TB in as little as two hours, compared to the prevailing standard of as long
as two months. Besides the technological breakthrough, it marks a significant improvement in the struggle to secure patient
compliance. If a physician can obtain a diagnosis without the patient having to make a return visit, prospects for tracking
and monitoring that patient's treatment will soar. Again, the PDP approach paid dividends. While a private company did much
of the heavy lifting in creating the product, it was Gates Foundation money that provided the incentive.
Window on the Future
Looking forward, expansion of the PDP approach will depend heavily on a record of results in the form of new products developed,
approved, and circulating in the market. Thus, convener groups like the TB Alliance are the crucible for success. Observers
also note that through the partnering that represents the essence of the PDP model, overall development costs for new drugs
will be lower, which will attract additional entrants to the field.
What is likely is a broadening of the PDP concept as society's definition of a "neglected disease" expands beyond infectious
conditions of the very poor to chronic ills of the more affluent, such as diabetes and heart disease, where it is not only
the efficacy of the drug that matters, but how it is delivered, and to whom. PDP lessons learned here are every bit as applicable
to the rich, mature markets as they are to the developing and emerging countries. And universality bespeaks legitimacy.